Vietnam MOH registration 240001830/PCBB-HCM

Quantitative Na+ Test Electrode

VN: Điện cực xét nghiệm định lượng Na+

Vietnam·Risk Class TTBYT Loại B·Sodium Electrode·Roche Diagnostics International Ltd·Registered Aug 16, 2024

Registration details

Analysis ID: 240001830/PCBB-HCM
Submission ID: 000.00.19.H29-240814-0003
Product Type: Sodium Electrode
Product Code: 03111598180

Company information

Manufacturer: Roche Diagnostics International Ltd
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: The Na+ electrode is used with the cobas b 221 <4> and <6> configurations in the local test environment to determine the concentration of Na+ in whole blood, serum, plasma, and solutions containing acetate and bicarbonate, and in liquid media, such as quality control test materials. Additionally, the electrode contributes to the determination of Hematocrit (Hct) by the measurement of conductivity in whole blood and liquid media, such as quality control test materials

Dates and status

Registration Date: Aug 16, 2024

About this record

Access comprehensive regulatory information for Quantitative Na+ Test Electrode in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240001830/PCBB-HCM and manufactured by Roche Diagnostics International Ltd. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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